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ITS Online Training Courses

GAMP® 5 (3 Day) Training Course

Takes place on 5th – 7th May 2020

The GAMP® 5 (3 Day) Training investigates in depth the main topics in the latest version of GAMP® 5:

A Risk-Based Approach to Compliant GxP Computerised Systems, and reviews sample appendices from the following sections:

  • Development
  • Management
  • Operation
  • Special Interest Topics

This course is useful for people working in healthcare manufacturing and related IT departments, as well as suppliers to the healthcare sector.

If you want a full working understanding of current regulatory thinking on computerised systems in industry, for IT, process control systems and manufacturing/packaging equipment, why not attend our course?

ISPE owns the GAMP trademark

Full course details here.

Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity Training Programme

Takes place on 2nd – 4th June 2020

The Understanding Validation, GAMP® 5, 21 CFR Part 11 and Data Integrity (3 Day) Training Programme provides learners with the opportunity to attend one course alone, a mix of the following courses or all three in their entirety, over three consecutive days.

The complete programme allows learners to build a basic knowledge of:

  • Validation
  • The latest GAMP® 5 guidance
  • The American regulatory requirements for 21 CFR Part 11 Electronic Records; Electronic Signatures
  • Data Integrity.

The programme comprises Understanding Validation Training (Day 1), GAMP® 5 Training – Fundamentals of GAMP® 5

Guidance Training (Day 2) and Interpreting 21 CFR Part 11 and Revised EU Annex 11

Data Integrity Training (Day 3).

ISPE owns the GAMP trademark www.ispe.org

Full course details here.

Introducing GMP, Root Cause Analysis & Understanding Validation Training Programme

Takes place on 23-25 June 2020

The Introducing GMP, Root Cause Analysis and Understanding Validation (3 Day) Training Programme provides learners with the opportunity of either taking one course alone, a mix of the following courses or all three in their entirety, over three consecutive days. 

The complete programme allows learners to build a basic knowledge of

  • GMP
  • Gain an insight into Root Cause Analysis
  • An understanding of validation requirements in the healthcare industry 

The programme comprises Introducing GMP Training (Day 1)

Root Cause Analysis Training (Day 2)

Understanding Validation Training (Day 3).

Full course details here.

Understanding Corrective and Preventive Action Systems (CAPA) Training Course

Takes place on 2nd July 2020

ITS’ Understanding Corrective and Preventive Action Systems (CAPA) Training Course provides an understanding of how to run effective Corrective and Preventive Action (CAPA) systems that will benefit your business and satisfy the regulators.

The CAPA training course covers areas that can cause confusion including:

  • Terms
  • definitions
  • deviations
  • non-conformances
  • use of corrections, corrective and preventive actions.

Course activities include applying the CAPA system and root cause analysis to a potential real case scenario.

Full course details here.